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A Prospective Randomized Controlled Study on Precise Repair of Midfacial Tumor Defect with Composite Tissue Flap and Digital Virtual Prototype Technology

A Prospective Randomized Controlled Study on Precise Repair of Midfacial Tumor Defect with Composite Tissue Flap and Digital Virtual Prototype Technology

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058192
Enrollment
Unknown
Registered
2022-04-01
Start date
2022-05-01
Completion date
Unknown
Last updated
2023-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Midfacial Tumor

Interventions

Experimental Group:The core technologies of this experiment were used to repair the defects in the middle area of the surface, including the evaluation and design of digital virtual technology before
Control Group:Covered with conventional skins or covered with open space or pseudo-compounds.

Sponsors

Beijing Tongren Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with malignant tumors in the middle of the face diagnosed by pathology [staging refer to AJCC-TNM staging the eighth edition], and there may be defects left after surgery, undergo phase I surgical repair; 2. Age 18-80 years old; 3. Initial treatment of patients (primary, no history of surgery, radiotherapy and chemotherapy); 4. KPS score of 80 points or above; 5. The patient has no contraindications to surgery or other factors of the test; 6. Patients voluntarily join the group, sign informed consent, and have good compliance.

Exclusion criteria

Exclusion criteria: 1. Patients with distant metastases; 2. Those who have central nervous system disorders or lose self-awareness due to mental illness; 3. Major organ dysfunction (including heart, lungs, liver, kidneys, etc.); 4. Those who have other malignant tumors within two years.

Design outcomes

Primary

MeasureTime frame
University of Washinqton head and neck Quatity-of-life, UW-QOL;

Secondary

MeasureTime frame
Eye function;Middle ear function;Nasal function;Oral function;Oral health assessment;Pronunciation function assessment;Assessment of swallowing function;Total quality of life assessment;Imaging assessment;

Countries

China

Contacts

Public ContactZhong Qi

Beijing Tongren Hospital Affiliated to Capital Medical University

zhongqi_ent@126.com+86 13520298736

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026